MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON RCI; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number IPN913776

Device Problems Melted (1385); Material Separation (1562)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 02/19/2022

Event Type  Injury  

Event Description

The patient was on a heated trach mask set at 37c.The respiratory therapist noted while doing last rounds, that the heated wire tubing was pulled off the adaptor connected to the concha, exposing the heated wires.The heater was reading 44c.The heater was turned off until it cooled down and then reconnected.Rn had noticed that the tubing had melted to the bed sheet.The tubing was also under the patient¿s gown, causing a superficial first and second burn on his side/stomach.The tubing and concha were replaced, and the machine is now working properly.Manufacturer response for humidifier, respiratory gas, (direct patient interface), hudson rci (per site reporter) humidifier device given to medline hospital representative.

• Brand Name: HUDSON RCI
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX MEDICAL; po box 12600; durham NC 27709
• MDR Report Key: 13691359
• MDR Text Key: 286737376
• Report Number: 13691359
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2022,02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN913776
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31025 DA
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White